Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 37041–37060 of 38,428 recalls
Recalled Item: CareStream Dental CS 2200 X-ray system Product Usage: The expected
The Issue: There have been approximately 2% of the x-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The
The Issue: Instratek, Inc.has received multiple complaints of the 1052
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by
The Issue: The low contrast pins in the Image Quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Becton
The Issue: Clinical diagnostic instrument may exhibit minor defects, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR)
The Issue: A patient was seriously mistreated after a user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab
The Issue: RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These
The Issue: RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLab
The Issue: RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint
The Issue: RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab
The Issue: RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These
The Issue: RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLab
The Issue: RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeVeen Standard Needle Electrode System
The Issue: Leveen Standard and Leveen Coaccess Needle Electrode System,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leveen Coaccess Introducer Set. Disposable
The Issue: Leveen Standard and Leveen Coaccess Needle Electrode System,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable
The Issue: Leveen Standard and Leveen Coaccess Needle Electrode System,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BariAir Therapy System The BariAir Therapy System is a risk
The Issue: KCI has issued a medical device correction for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS System versions 3.X and higher and 4.X and
The Issue: There is a potential loss of image(s) associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System
The Issue: Some units of Trilogy shells manufactured since March
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System
The Issue: Some units of Trilogy shells manufactured since March
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is
The Issue: Some units of Trilogy shells manufactured since March
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.